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AssigneePalmaya Pty Ltd
InventorsAlexander George B. O'Neil, Yandi Liu
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A pharmaceutical preparation adopted for sustained release of an active agent(s) over an extended period of time at a therapeutic rate without an initial burst release of the agent(s) upon administration, wherein the preparation comprises: (i) an outer portion prepared from one or more layers of a biodegradable polymer, which is selected to release an active agent over an extended period of time when positioned in situ in a patient, and (ii) an inner portion comprising a plurality of micro-capsules formed from at least a biodegradable polymer, said micro capsules containing at least an active agent, wherein the micro-capsules are compressed into the form of a tablet under suitable pressure to suppress the rate of release of the active agent from the micro-capsules. The present specification also relates to a method for inserting one or more implants(s) into a tissue of a mammal comprising the following steps: a) making a small incision into the tissue with a needle and a first sheath; b) withdrawing the needle from the first sheath but leaving the first sheath in the tissue; c) dilating the opening of the incision by inserting a dilator and second sheath of larger diameter through the body of the first sheath; d) withdrawing the dilator from the second sheath, but leaving the second sheath in the tissue; e) disturbing the implant(s) from a sheath filled with implant(s) by inserting said sheath into the final sheath inserted into the tissue and pushing a dilator into the sheath thereby releasing said implant(s) into the tissue.
A pharmaceutical preparation adapted for sustained release of an active agent(s) over an extended period of time at a therapeutic rate without an initial burst release of the agent(s) upon administration, wherein the preparation comprises:
A pharmaceutical preparation according to any one of the preceding claims wherein the suitable pressure is proportional to the lifespan of the implant and is inversely proportional to delivery rate.
A pharmaceutical preparation according to any one of the preceding claims wherein the suitable pressure is high pressure.
A pharmaceutical preparation according to any one of the preceding claims wherein the size of the micro-capsules is greater than 12 microns.
A pharmaceutical preparation according to any of the preceding claims wherein the active agent is a naltrexone.
A pharmaceutical preparation according to any one of the preceding claims wherein the pharmaceutical preparation is designed for subcutaneous administration.
A pharmaceutical preparation according to any one of the preceding claims wherein the release rate is about 0.1 mg per day to 30 mg per day.
A pharmaceutical preparation according to any of the preceding claims wherein the effective amount of active agent administered is 2.0 to 10 g.
A pharmaceutical preparation according to any one of the preceding claims wherein the effective amount of active agent is 3.6 g to 7.2 g.
A pharmaceutical preparation according to any one of the preceding claims wherein the percentage of active agent released is 0.1% to 10% per day.
A pharmaceutical preparation according to any one of the preceding claims wherein the length of time over which active agent is released more than 40 days.
A pharmaceutical preparation according to any one of the preceding claims wherein the biodegradable polymer is long lasting.
A pharmaceutical preparation according to any one of the preceding claims wherein the biodegradable polymer is selected from any one of polymer(glycolic acid) poly-DL-lactic acid, poly-L-lactic acid, copolymers of the foregoing, poly(aliphatic carboxylic acids), copolyoxalates, polycarprolocatone, polydioxonone, poly(ortho carbonates), poly(acetals), poly(lactic acid caprolactone), polyorthoesters, poly(glycolic acid caprolactone), polyanhydrides, and natural polymers including albumin, casein, and waxes, such as, glycerol mon-and distearate, and the like.
A pharmaceutical preparation according to any one of preceding claims wherein the pharmaceutical preparation comprises one tablet which is coated with at least one layer of biodegradable polymer.
A pharmaceutical preparation according to any one of the preceding claims wherein the pharmaceutical preparation comprises plurality of tablets coated with at least one coating of biodegradable polymer.
A pharmaceutical preparation according to any one of the preceding claims wherein the pharmaceutical preparation comprises tablets comprising one or more active agents, each active agent having different rates of release.
A pharmaceutical preparation according to any one of the preceding claims wherein the thickness of the coating(s) of one or more biodegradable polymer is 0.001 mm to 1 mm.
A pharmaceutical preparation according to any one of the preceding claims wherein the pharmaceutical preparation comprises a pharmaceutical excipient.
A method for inserting one or more implant(s) into a tissue of a mammal comprising the following steps:
A method according to any of the preceding claims wherein the method is administered on a mammal.
Dependencies are inferred from the claim text.